Office of Clinical Research

Mission

The Memorial Hermann Office of Clinical Research exists to encourage and facilitate the conduct of high-quality, cost-effective clinical research at Hermann and affiliated facilities.

Services

Investigational Drug Services

The Memorial Hermann-Texas Medical Center Investigational Drug Services offers a full range of services related to clinical trials. The most common activity is preparation and dispensing of investigational drugs and placebos. The IDS ensures that medications are available as needed and dispensed according to protocol requirements. When appropriate, the IDS can counsel subjects about their medications, aid in promoting protocol adherence and support data collection or protocol development. The IDS maintains a complete copy of the protocol for each study with which it is involved

Assistance with Budgeting

The Office of Clinical Research can assist Investigators with budgeting for their studies during negotiations with sponsors. Our new, standardized research pricing offers consistent charging at discounted rates for studies.

Research History by Major Areas of Study

What's New

Application Assistance Service
A new service beginning in December 1999 will offer assistance with the sometimes-bewildering array of forms and copies that must be completed to begin a new study. The Office of Clinical Research will offer a service through which we will assist with the completion of research application forms to the Committee for the Protection of Human Subjects (CPHS), hospital and/or Clinical Research Center (CRC). Our staff will also make the required copies and deliver the applications, serving as a liaison for study staff and these institutions.

Simplified Billing Statements
The Office of Clinical Research will now send statements which include a monthly activities summary followed by details of current study charges grouped by study subject. If notified beforehand, the office can arrange for statement schedules that match sponsor payment schedules with Investigators.

New Statement Format
In response to Investigator and research staff comments, the Office of Research has designed a new format for monthly billing statements. Itemization of statements is now grouped by study subject.

Standardized Pricing
A standardized pricing list for clinical research has been developed at substantial discounts off regular rates. Contact the Office of Research for more information.

Research Application Service
The Memorial Hermann Office of Clinical Research is offering a new service to assist with research applications to the CPHS, GCRC and/or the hospital.

Centralized Budgeting
All budgeting and pricing for procedures and other items related to research may now be obtained by calling the Office of Research at (713) 704-4255.

Applications Software
Tired of filling out the same information three times when you apply to Memorial Hermann, CPHS and the GCRC? The Office of Research has created software that allows you to fill in information such as the protocol title that is common to all three applications only once. Please contact Chris Jimmerson at (713) 704-5179 if you would like to try it.

Coming Soon

Expanded, Improved IDS
Over the next year, the IDS staff will be expanded to serve Investigators better. A pharmacist and pharmacy technician will be available during morning, afternoon and evening hours, seven days a week, with a pharmacist on call 24 hours daily. Current staff will be expanded to two full-time pharmacists and 1.4 FTE pharmacy technicians.

Improved Ordering Systems
The office of research is redesigning ordering for research to increase accuracy. The redesign will include both new ordering sheets and a computerized order entry system. We are currently seeking advice from Investigators and their staff. Please contact us if you would be interested in participating in this redesign.

Subject Referral Information
Coming soon on this web site, a subject referral listing will allow Investigators to list their clinical trials by specialty. Information will include a description of each study, basic entry criteria and contact information. By listing their trials in this service, Investigators can make their trials available for referrals from throughout the Memorial Hermann Healthcare System. Likewise, physicians treating patients may check the listings periodically to find out of there are trials available that might be of benefit.

Contact Information

Memorial Hermann Office of Clinical Research
6411 Fannin
Mail Stop 90
Houston, TX 77030-1501
Phone: 713-704-4220
Fax : 713-704-5124
General E-mail: research@memorialhermann.org

Contact the research office for the following:

Research pricing information
Research applications
Account set-up
Research order screens
Billing stickers
Billing queries
General information

Memorial Hermann Research Approval Process

1. The Investigator contacts the Research Office for prices for tests, procedures and other hospital services required by the proposed study.
2. The Research Office prepares a price list for hospital services required by the study which the investigator may use help to negotiate with sponsor.
3. The Investigator submits the Hermann research application with the C.P.H.S application packet to the C.P.H.S. Office by the first Friday of the month.
4. The Research Office receives application packet from C.P.H.S.
5. The Research Office reviews application packet and forwards copies to involved hospital departments (clinics, pharmacy, radiology, inpatient units, etc.)
6. The departments return evaluation forms to the Research Office, indicating approval/disapproval of the department’s involvement in the study and noting any research-related costs that should be billed to the study.
7. When all department approvals and C.P.H.S. approval are received, The Research Office prepares the Hermann research approval letter and budget worksheet (if applicable) and forwards for budget review and administrative signatures.
8. The Research Office forwards the signed approval letter and budget worksheet to the Investigator for his/her signature, with appropriate enclosures (chart I.D. stickers, pt. enrollment form, lab result routing form). Copies are also routed to all co-investigators, billing contact, research nurse, and Hermann departments involved in the study.
9. When the Investigator sends a copy of his signature on the approval letter to the Research Office, a research billing account is set up. A research order entry screen is also set up (for inpatient studies only at this time). Research billing stickers are prepared and sent to the Investigator, with notification of account activation and/or research order screen activation. The Investigator may now begin enrolling patients.
10. When the Investigator writes inpatient research orders, they should be entered in the research order screen. Outpatient service requisitions should reference the study account number or have a billing sticker (provided by Research Office) affixed. These processes help assure that research-related services are billed directly to the study’s account, rather than to the patient.
11. Statements are sent monthly to the billing contact designated on the Hermann research application. The statements should be reviewed immediately and any errors brought to the attention of the Research Office. (Any errors not reported within 21 days are the responsibility of the investigator.)

American Cancer Society (http://www.cancer.org/)

Cancer.gov - National Cancer Institute's comprehensive cancer information web site (http://www.cancer.gov/)

Centers for Disease Control and Prevention (http://www.cdc.gov/)

Centers for Medicare & Medicaid Services (CMS) (http://www.cms.hhs.gov/)

ClinicalTrials.gov - Linking patients to medical research - A service of the National Institutes of Health developed by the National Library of Medicine (http://clinicaltrials.gov/)

Committee for the Protection of Human Subjects (CPHS) (http://www.uth.tmc.edu/ut_general/research_acad_aff/orsc/submissioninstructions.htm)

The Federal Register (FR) (http://www.gpoaccess.gov/fr/index.html)

Food and Drug Administration (http://www.fda.gov/)

National Cancer Institute (http://www.nci.nih.gov/)

National Comprehensive Cancer Network (NCCN) (http://www.nccn.org/)

National Institutes of Health (http://www.nih.gov/)

National Library of Medicine (http://www.nlm.nih.gov/)

Texas Medical Center - Academic and Research Institutions (http://www.tmc.edu/institutions/)

University Clinical Research Center (UCRC) (http://oac.hsc.uth.tmc.edu/uth_orgs/crc/)

Memorial Hermann Research History by Major Areas of Study

Department/Area of Expertise Percent

Pediatrics 16.02%

Anesthesiology 13.67%

Cardiology
13.54%

Neurology 12.29%

Infectious Diseases 8.84%

OB/GYN 5.39%

Transplant 4.28%

Gastroentorology 3.87%

Pulmonary/Critical Care 3.18%